Flow Sensor System Including Spring Contacts

ABSTRACT

A flow sensor sub-assembly for sensing flow of a fluidic medicament is disclosed. The flow sensor sub-assembly includes a first spring contact and a second spring contact. The spring contacts are secured to a base that has a circuit for conducting an electrical signal to and from the spring contacts to a microprocessor. The first spring contact is in electrical communication with a first piezo element and the second spring contact is in electrical communication with a second piezo element. The first spring contact has a first contact force against the first piezo element and the second spring contact has a second contact force against the second piezo element, and the first and second contact forces are equivalent. A circuit board for interfacing to a flow sensor having a plurality of piezo elements for transmitting a flow signal indicative of flow of fluidic medicament is also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application No.17/861,827, filed Jul. 11, 2022, which is a continuation of U.S. Pat.Application No. 16/676,867, filed Nov. 7, 2019 (now U.S. Pat. No.11,415,440), which is a continuation of U.S. Pat. Application No.16/381,542, filed Apr. 11, 2019 (no U.S. Pat. No. 10,514,284), which isa continuation of U.S. Pat. Application No. 15/957,051, filed Apr. 19,2018 (now U.S. Pat. No. 10,302,473), which is a continuation of U.S.Pat. Application No. 15/247,084, filed Aug. 25, 2016 (now U.S. Pat. No.9,976,883), which claims the benefit of U.S. Provisional Pat.Application No. 62/211,116, filed Aug. 28, 2015, the disclosures of eachof which are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION Field of the Disclosure

The present disclosure relates generally to a flow sensor system. Moreparticularly, the present disclosure relates to a flow sensor system forproviding intravenous bolus injections of medication to a patient whichprovides healthcare professionals with an automated record ofmedication, concentration, volume, dose, and time of each injection.Preferably, the system has an ultrasonic flow sensor.

Description of the Related Art

There is a need to reduce medication error at bedside during bolusdelivery. It would be advantageous to provide a record of, andelectronically measure, bolus delivery which allows monitoring bolusdelivery and automatic documentation of bolus delivery as part of apatient’s health record. Additionally, it would be advantageous toprovide alerts when bolus delivery inconsistent with a patient’s medicalrecord is about to occur.

SUMMARY OF THE INVENTION

The present disclosure provides a system for sensing flow of a fluidicmedicament. The system includes an intelligent injection port which mayattach to an injection site (such as a “Y Site” or a stop cock) formanually administered IV injections. The system includes two mainsub-assemblies: a single-use flow sensor and a reusable base unit, whichfit together prior to use.

The flow sensor sub-assembly includes a first spring contact and asecond spring contact. In one embodiment, the spring contacts aresecured to a base having a circuit for relaying an electrical signal toa microprocessor. The first spring contact is in electricalcommunication with a first piezo element and the second spring contactis in electrical communication with a second piezo element. The firstspring contact has a first contact force against the first piezo elementand the second spring contact has a second contact force with the secondpiezo element, and the first contact force is equivalent to the secondcontact force. The present disclosure also provides a circuit board forinterfacing to a flow sensor having a plurality of piezo elements fortransmitting a flow signal indicative of flow of a fluidic medicament.

In accordance with an embodiment of the present invention, a flow sensorsub-assembly for sensing flow of a fluidic medicament includes: a flowtube having a flow tube inlet and a flow tube outlet, through which saidmedicament flows. The flow sensor sub-assembly also includes a firstpiezo element arranged at an upstream position of the flow tube and asecond piezo element arranged at a downstream position of the flow tube,with the first piezo element and the second piezo element mounted apre-selected distance apart from each other. The flow sensorsub-assembly also includes a first spring contact, and a second springcontact, wherein each of said spring contacts are secured to a base,wherein the base has a circuit for conducting an electrical signal toand from the spring contacts to a microprocessor, and the first springcontact is in electrical communication with the first piezo element andthe second spring contact is in electrical communication with the secondpiezo element. The first spring contact has a first contact forceagainst the first piezo element and the second spring contact has asecond contact force against the second piezo element, and the firstcontact force is equivalent to the second contact force.

In one configuration, the flow tube further includes an inner flow tubeand end fittings for securing the inner flow tube to the end fittings,and the first and second piezo elements are mounted to the end fittings.In another configuration, said first spring contact includes a pair ofcantilevered leaf springs, with the second spring contact including apair of cantilevered leaf springs. In yet another configuration, saidcircuit is provided on a front and rear surface of a PCB board and thefirst and second spring contacts are resiliently urged against the firstand second piezo elements, respectively, when the first and second piezoelements are inserted between each of said pair of cantilevered leafsprings. In one configuration, the circuit is formed integrally with aflow sensor housing by injection molding. In another configuration, thefirst piezo element and the second piezo element are annular in shapeand encircle the flow tube at each respective mounting point.

In yet another configuration, the flow sensor sub-assembly is containedwithin a flow sensor housing, wherein the flow sensor housing is coupledto a flow sensor base which contains the microprocessor and the circuitincludes connecting pins for providing the electrical signal from theflow sensor sub-assembly to the microprocessor within the flow sensorbase. In one configuration, the flow sensor sub-assembly is disposed ofafter the flow sensor sub-assembly is used to sense the flow of at leastone fluidic medicament. In another configuration, the flow sensor baseis usable with a different flow sensor sub-assembly.

In accordance with another embodiment of the present invention, acircuit board for interfacing to a flow sensor having a plurality ofpiezo elements for transmitting a flow signal indicative of flow of afluidic medicament includes: a base having a plurality of electricalcircuit traces having a first end and a second end, a first pair ofspring contacts for biasing against an electrical interface with a firstpiezo element, the first pair of spring contacts are mounted to thefirst end of the base and in electrical communication with at least oneelectrical circuit trace. The circuit board further includes a secondpair of spring contacts for bias and electrical interface with a secondpiezo element, the second pair of spring contacts are mounted to thesecond end of the base and in electrical communication with at least oneelectrical circuit trace, and a plurality of pins in electrical contactwith the plurality of electrical circuit traces. Each of the springcontacts are pre-configured such that the bias against the first piezoelement and the bias against the second piezo element are equivalent andthe electrical circuit traces are configured such that each of the pinsare in electrical communication with a single spring contact.

In one configuration, each pair of spring contacts includes a pair ofcantilevered leaf springs mounted to the base. In another configuration,the electrical circuit traces are provided on a front surface of thebase and the spring contacts extend from a rear surface of the base. Inyet another configuration, the circuit board is formed integrally with aflow sensor housing by injection molding. In one configuration, each ofthe cantilevered leaf springs further includes a mound-like protrusionwhich contacts a surface of the piezo elements. In anotherconfiguration, the circuit board is assembled into a flow sensor housingin at least two orientations and provides transmission of the flowsignal from the piezo elements to a microprocessor. In yet anotherconfiguration, the circuit board is disposed of after the flow sensor isused to sense the flow of at least one fluidic medicament. In oneconfiguration, after the flow sensor is used to sense the flow of atleast one fluidic medicament, the circuit board is usable with adifferent flow sensor.

In another configuration, the first spring contact includes a pair ofopposed cantilevered leaf springs engaging a forward contact point onthe first piezo element and an aft or downstream contact point on thefirst piezo element. The second spring contact includes a pair ofopposed cantilevered leaf springs engaging a forward contact point onthe second piezo element and an aft or downstream contact point on thesecond piezo element. In yet another configuration, the first springcontact includes a bifurcated cantilevered leaf spring engaging thefirst piezo element, and the second spring contact includes a bifurcatedcantilevered leaf spring engaging the second piezo element.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a distally-directed perspective view of a flow sensor systemin accordance with an embodiment of the present invention.

FIG. 2 is a proximally-directed perspective view of a flow sensor systemin accordance with an embodiment of the present invention.

FIG. 3A is a proximal elevation view of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 3B is a distal elevation view of a flow sensor system in accordancewith an embodiment of the present invention.

FIG. 4A is a side elevation view of a flow sensor system in accordancewith an embodiment of the present invention.

FIG. 4B is an enlarged detail view of a portion of FIG. 4A asillustrated by Detail A.

FIG. 5A is a perspective view of a base of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 5B is a perspective view of the base of FIG. 5A illustrating theoptical and electrical components.

FIG. 6 is a perspective view of a flow sensor of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 7 is another perspective view of a flow sensor of a flow sensorsystem in accordance with an embodiment of the present invention.

FIG. 8 is an exploded, perspective view of a flow sensor of a flowsensor system in accordance with an embodiment of the present invention.

FIG. 9 is a perspective view of a flow sensor of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 10A is a side elevation view of a syringe compatible with a flowsensor system in accordance with an embodiment of the present invention.

FIG. 10B is an enlarged detail view of a portion of FIG. 10A asillustrated by Detail B.

FIG. 10C is a side elevation view of a tip label for a syringecompatible with a flow sensor system in accordance with an embodiment ofthe present invention.

FIG. 11A is a perspective view of a charger for a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 11B is an enlarged detail view of a portion of FIG. 11A rotated ata clockwise angle as illustrated by Detail C.

FIG. 11C is a top elevation view of a charger for a flow sensor systemin accordance with an embodiment of the present invention.

FIG. 11D is a cross-sectional view taken along line X-X of FIG. 11C,with a base of a flow sensor system received within a portion of thecharger, in accordance with an embodiment of the present invention.

FIG. 12 is a perspective view of a flow sensor and a mount in accordancewith an embodiment of the present invention.

FIG. 13 is a perspective view of a flow tube sub-assembly in accordancewith an embodiment of the present invention.

FIG. 14A is a schematic representation of a computer display in ananesthesia view in accordance with an embodiment of the presentinvention.

FIG. 14B is a schematic representation of a computer display in atabular view in accordance with an embodiment of the present invention.

FIG. 15 is a perspective view of a circuit board in accordance with anembodiment of the present invention.

FIG. 16A is an assembled view of a flow tube sub-assembly and a circuitboard, with spring contacts engaged with and in electrical communicationwith respective piezo elements, in accordance with an embodiment of thepresent invention.

FIG. 16B is an enlarged detail view of a first portion of FIG. 16A asillustrated by Detail D.

FIG. 16C is an enlarged detail view of a second portion of FIG. 16A asillustrated by Detail E.

FIG. 17 is a perspective view of a spring contact in accordance with anembodiment of the present invention.

FIG. 18 is a perspective view of a contact area of a spring contact inaccordance with an embodiment of the present invention.

FIG. 19A is a first partial elevation view of a portion of a flow tubesub-assembly and a circuit board, with a spring contact engaged with andin electrical communication with a piezo element, in accordance with anembodiment of the present invention.

FIG. 19B is a second partial perspective view of a portion of a flowtube sub-assembly and a circuit board, with a bifurcated spring contactengaged with and in electrical communication with a piezo element, inaccordance with an embodiment of the present invention.

FIG. 20 is an elevation view of a flow tube sub-assembly in accordancewith an embodiment of the present invention.

FIG. 21 is a perspective view of a circuit board with spring contacts inaccordance with an embodiment of the present invention.

FIG. 22A is an assembled view of a portion of a flow tube sub-assemblyand a circuit board, with a spring contact engaged with and inelectrical communication with a piezo element, in accordance with anembodiment of the present invention.

FIG. 22B is a perspective view of a spring contact mount to a circuitboard in accordance with an embodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

As used herein, proximal shall refer to a part or direction located awayor furthest from a patient (upstream), while distal shall refer to apart or direction towards or located nearest to a patient (downstream).Also, a drug substance is used herein in an illustrative, non-limitingmanner to refer to any substance injectable into the body of a patientfor any purpose. Reference to a patient may be to any being, human oranimal. Reference to a clinician may be to any person or thing givingtreatment, e.g., a nurse, doctor, machine intelligence, caregiver, oreven self-treatment.

FIGS. 1-12 illustrate an exemplary embodiment of a flow sensor system200 of the present disclosure. Referring to FIGS. 1-12 , a flow sensorsystem 200 of the present disclosure includes two main assemblies whichfit together prior to use: a flow sensor 210 and a base 220. In oneembodiment, the flow sensor 210 can be a single-use flow sensor which isengageable with reusable base 220. The flow sensor system 200 is anintelligent injection port. The flow sensor system 200 is attachable toan injection site (“Y Site” or stop cock, for example) for manuallyadministered IV injections.

The flow sensor system 200 of the present disclosure can reducemedication error at bedside during bolus delivery. The flow sensorsystem 200 of the present disclosure can also provide a record of andelectronically measure bolus delivery, which allows monitoring bolusdelivery and automatic documentation of bolus delivery as part of apatient’s health record. The flow sensor system 200 of the presentdisclosure can also provide alerts when bolus delivery inconsistent witha patient’s medical record is about to occur.

Referring to FIG. 1-5B, in one embodiment, the base 220 is anon-sterile, reusable device that houses a battery, a scanner (eitheroptical, mechanical, inductive, capacitive, proximity, or RFID),electronics, and wireless transmitter. In some embodiments, the base 220is battery powered, and rechargeable. In some embodiments, each base 220has a unique serial number imprinted on a surface of the base 220 orembedded therein that may be transmitted to a data system before use.The data system can be a local computer or tablet “Computer”, a cellularphone, another medical device, or a Hospital Data System.

In one embodiment, the base 220 is removably connectable to the flowsensor 210. Referring to FIGS. 5A and 6-9 , the base member 220 and themechanical connection of the flow sensor 210 to the base member 220 isdescribed. The base member 220 includes at least one deflectable wingtab 280 defining an opening for receiving at least a portion of the flowsensor 210 therein and for securing the flow sensor 210 within a portionof the base 220 prior to use. In one embodiment, a pair of wing tabs 280secure the flow sensor 210 within the base 220. Optional gripping ribs395 may be provided on an exterior profile for enabling a user to graspthe base portion 220.

An interior profile of the wing tab 280 may be provided with a catch 389for corresponding engagement with a tab 189 provided on the flow sensor210, as shown in FIG. 6 , to restrain the flow sensor 210 within thebase 220, as will be discussed further herein. The wing tabs 280 may beflexible to the extent that they may be outwardly deflected to allow forpassage of the flow sensor 210 thereover. The interior of the wing tab280 may be provided with a pin cam 388 which allows a pin 188 of theflow sensor 210, as shown in FIG. 7 , to ride along such that the flowsensor 210 is moved proximally during assembly onto the base 220, toprecisely align various optical and electrical components of the flowsensor 210 and the base member 220, as will be discussed further herein.

Referring to FIGS. 5B and 6-9 , the base member 220 and the electricalconnection of flow sensor 210 to the base member 220 is described. Thebase 220 includes an activation/engagement button 350 which allows foran indication that the flow sensor 210 has been engaged with the base220. In one embodiment, the activation/engagement button 350 signals toa microprocessor within the base 220 that a syringe has been properlyengaged with the sensor 210 and its injection port 130.

The base 220 further includes a plurality of contacts 386 (FIG. 5B) forelectrically engaging corresponding electrically active portions of theplurality of contact pins 385 (FIG. 7 ). A contour protrusion 488surrounds at least a portion of the tongue 286. As shown in FIG. 7 , abottom surface of the sensor 200 includes a pin seal 384 surrounding aplurality of contact pins 385 to prevent contamination, thus minimizingelectrical disruptions. In some embodiments the plurality of pins 385comprise a four pin connector with two pins electrically connected toeach piezo element 150, 151, as will be discussed further. In otherembodiments, the plurality of pins 385 comprise a six pin connector withtwo pins electrically connected to each piezo element 150, 151 and twopins electrically connected to a battery (not shown) in the flow sensor210.

The base member 220 further includes a tongue 286 surrounded by ashoulder 486 having a plurality of contacts 386 for electricallyengaging corresponding electrically active portions of sensor 200 and acharger 900 (FIG. 11A), as will be discussed herein.

Referring to FIGS. 1-4B, 6-9, and 13 , in one embodiment, the flowsensor 210 is a pre-sterilized disposable having an injection port 130and a distal tubing connection, such as a Luer tip 109.

The flow sensor 210 may include a flow tube sub-assembly 10 consistingof a flow tube 100 having an outlet end 101 and an inlet end 102. Theoutlet end 101 may be provided in fluid communication with an outlettubing 110 having an outlet connection 105 including a Luer tip 109which may be optionally covered by a Luer cap 108. In a preferredembodiment, the outlet connection 105 is a plastic connector with a Luertip 109, however, any suitable method to inject the medicament into apatient is envisaged to be within an aspect of an embodiment of theinvention. For example, it may be desirable to replace the outletconnection 105 and tubing 110 with a needle for directinjection/infusion into a patient. Furthermore, it may be desirable tointegrate the base 220 into a medication pen or infusion device for thedelivery of insulin.

The inlet end 102 may be coupled to the reservoir of a medication pen orinfusion reservoir. The inlet end 102 of the flow tube 100 may beprovided in fluid communication with an injection port 130, and mayoptionally include a connection such as a threaded Luer lock 131 whichis engageable with a source of a fluid to be injected. A pierceableseptum 139 may be provided with the injection port 130 for maintainingsterility prior to use.

In a preferred embodiment, the injection port 130 is a plastic containerwith a split septum 139, however, any suitable method to inject themedicament through a flow sensor inlet 180 to a patient is envisaged tobe within an embodiment of the present invention. For example, it may bedesirable to replace the injection port 130 for direct connection to amedicament delivery device. In addition, it may be desirable tointegrate the flow sensor inlet 180 to accept a direct fluidicconnection to a medication delivery device.

In one embodiment, the flow tube 100 is comprised of a medical gradestainless steel and is approximately 50 mm long with a 1.0 mm innerdiameter and a 1.6 mm outer diameter.

The flow sensor 210 also includes a first piezo element or upstreamtransducer 150 and a second piezo element or downstream transducer 151.The first piezo element 150 may be provided with an inlet fitting 180,as shown in FIG. 8 , for coupling with the injection port 130.Similarly, the second piezo element 151 may be provided with an outletfitting 190, for coupling with the outlet tubing 110.

The flow sensor 210 can be supplied in a sterile package for a singlepatient use. In one embodiment, labeling is printed on the individualsterile package. In one embodiment, each flow sensor 210 has a uniqueserial number imprinted on a portion of its surface. In someembodiments, there are electronics in the flow sensor 210 which retain aunique identifier. These identifiers are transmitted eitherautomatically or manually to a data system during use and datacollection. In one embodiment, at the inlet end 102 of a flow sensor 210the injection port 130 is a common needleless, Luer-Lok type. Typically,the inlet port or the injection port 130 is cleaned prior to giving aninjection according to hospital policy. Additionally, flushing the flowsensor 210 with an IV fluid (e.g., normal saline syringe) is desirablebefore use. The injection port 130 on the flow sensor 210 typicallysupports up to 100 injections. In one embodiment, the flow sensor 210has a male Luer-Lok connection, e.g., an outlet connection 105 having aluer tip 109, on a one-inch IV tubing pigtail at the outlet end 101.This male Luer-Lok connection may be attached to an IV line at a Y-siteor IV manifold. Each flow sensor 210 has a unique serial number, howeverit may be desirable to only display a portion of the serial number on aportion of the exterior of the flow sensor 210. For example, the last 4digits of the serial number may be imprinted on the surface next to itsbar code. This human readable number is used to visually identify a flowsensor 210 within wireless range of communication of a computer. In someembodiments, the flow sensor 210 measures with an accuracy of ± 5% forbolus volumes of 1.0 mL to 55 mL and ± 20% for bolus volumes of 0.4 to1.0 mL and has a dead-space volume of less than 0.3 mL.

Referring to FIGS. 11A-11D, in one embodiment, an optional separatecharger 900 is compatible with the flow sensor system 200 and rechargesa battery in the reusable base 220, if required, for reuse of the base220. Referring to FIGS. 11A-11D, in one embodiment, the charger 900includes a charger base 905 having an opening 925 for receiving the base220, the opening 925 having charging pins 950 which engage correspondingcontacts 386 in the reusable base 220. The charger 900 may include asloped floor 930 for allowing disinfection liquid to drain therefrom.The device may also include elevated feet 999 to assist in drainage.

Reusable bases are typically supplied non-sterile and requiredisinfection and charging before use. It is preferred to disinfect eachbase 220 before first use. Typical commercial hospital disinfectantsinclude alcohol-based quaternary ammonium, e.g., Metrex Research CaviWipes. In some embodiments, the base 220 can be used up to 500 times.Preferably, a rechargeable lithium ion battery is used within the base220 and is not removable from the base 220. It is envisaged that afully-charged base 220 will accommodate an entire patient case. In someembodiments, each base 220 is identified by labeling on the bottom ofthe device. Optionally, bases 220 are provided in individual boxes andeach box is in a case package. The charger 900 may also include a powerindicator 995. In one embodiment, when the base 220 is connected to acharger 900, up to four green light bars will illuminate on the top. Thenumber of solid green light bars indicates the level of charge. A greenblinking light on the base 220 will indicate it is recharging. In someembodiments, a useful life indicator is employed when the base 220 isconnected to a charger 900 by use of a red light that indicates that thebase 220 has exceeded its useful life. Optionally, on the Computer, anerror message will display when a flow sensor system 200 whose usefullife is completed is wirelessly connected to a tablet during patientsetup. It would then be desirable to replace the base 220 with anotherand repeat the wireless connection to the Computer. Optionally, the flowsensor system 200 is provided in a mount which is an appliance that fitsa standard Clarke socket to keep the flow sensor system 200 in place atthe patient’s bedside. Additionally, it may be desirable to clean anddisinfect the charger 900 by using the procedure used for cleaning anddisinfecting the base 220.

In one embodiment, the flow sensor system 200 supports injections usingany Luer-lock type syringe. For example, referring to FIGS. 10A-10C, theflow sensor system 200 is compatible with a syringe 800 that is labeled.In one embodiment, the syringe 800 includes scale markings 805, a distaltip 810, a luer tip 815, a proximal end 820, a flange 825, a tip label850 having human readable indicia 852 and machine readable indicia 854,a barrel label 860 having human readable indicia 862, and a plunger 890.

The base 220 of the flow sensor system 200 includes optics and a digitalcamera disposed within or behind a first window 360 (FIG. 2 ) capable ofreading the machine readable indicia 854 provided on a label 850 of anencoded syringe. The first window 360 may be precisely aligned with Luerlock threads 131 present on the flow sensor 210 when the flow sensor 210is assembled with the base 220, thus aligning the machine readableindicia 854 present on the label 850 on the syringe 800 during aninjection cycle and/or medication determination cycle. The base 220 mayfurther include a second window 370 (FIG. 5A) having a light source forproviding adequate lighting to the camera disposed within or behindwindow 360.

Additionally, the flow sensor system 200 is designed to work withencoded syringes that have a special barcode identifier on the Luercollar of the syringe, called “encoding”. Preferably, encoded syringesinclude commercially-available drugs in prefilled syringes with aspecial barcode that stores information about the medication containedwithin the syringe. Encoded syringes are ready-to-use, passive, anddisposable. The flow sensor system 200 also accommodates syringes nothaving encoding. The encoding syringes store the drug name andconcentration contained within the syringe. Additional characteristicssuch as drug source, container size, drug manufacturer source, drugcategory color, among others, may also be included. When an encodedsyringe is attached to the injection port 130 of the flow sensor 210,this barcode information is read by a scanner in the base 220 wirelesslytransmitted by the flow sensor system 200 to the data system.Preferably, the 2-D barcodes will be added to syringes during thefilling process.

In one embodiment, the flow sensor system 200 contains a device tocapture and transmit an image of a 2-D barcode on the Luer collar of thesyringe, and wirelessly transmit this image to a “Computer”. Typicallythe Computer is a tablet computer communicating with multiple flowsensor systems 200. The 2-D barcode contains data, typically includingthe name and concentration of the drug in the syringe among other data.The Computer decodes this image, and displays and announces the drugattached. The barcode can contain the drug name and concentration. Asthe drug is injected, the flow sensor 210 in conjunction with the base220 ultrasonically measures the volume of the injected drug and the timethe drug was administered. This information may be stored in the flowsensor system 200 for later transmission to the Computer. The Computeruses this information to provide clinicians with an automated record ofthe drug name, concentration, volume, dose, and time of injection. Themedication administration information is time stamped and displayed forclinical reference. Not all syringes used by the healthcare professionalwill contain a 2-D barcode. If a syringe without a 2-D barcode isinserted into the flow sensor system, the injection port 130, the flowsensor system 200 will prompt the user to manually enter the drug nameand concentration into the computer. Information that is manuallyentered into the flow sensor system 200 is included in the patientmedication record.

In one embodiment, the Computer can use a radio to wirelesslycommunicate with the flow sensor system 200 using an RF signal at 2.4GHz to form a local medical device network. A number of flow sensorsystems 200 and Computers may be used in the same vicinity such as apreoperative care area or a post anesthesia care unit (PACU). Alertmessages are communicated between the flow sensor system 200 and theComputer to advise the clinician of various operational characteristicsof the flow sensor system 200. Some of these alerts inform the clinicianof potential hazardous situations to allow user action to prevent harmto the patient or loss of medical data. Preferably, a lost wirelesscommunication message will display when communication is lost betweenthe flow sensor system 200 and the Computer. Preferably, all medicationadministration data from the flow sensor system 200 is transferred tothe specific patient’s medical record. In the event of a communicationloss, medication administration data will be stored locally at the flowsensor system 200 and transferred to the Computer when communicationsare resumed.

The Computer may operate in a variety of modes. Typically the Computerhas specialized flow sensor system 200 software for operations, a touchscreen, and a wireless communications (Radio). It is typically mountednear an anesthetist or nursing work envelope and it may be removed forhand-held use. When the Computer is used in a hospital having a paperanesthesia record, the Computer supports features that assist withdocumenting the flow sheet portion and may help clinicians make theright decisions. In this configuration, the Computer complements thepaper recordkeeping activities by tracking and displaying injectionsgiven through the flow sensor system 200. The Computer also enablesclinicians to manually document other pertinent IV drug injection andinfusion information.

In one embodiment, the software screens follow a three-step approachconsisting of: (1) connecting the flow sensor system 200 to theComputer; (2) setting up a patient’s flow sensor system 200 for use; and(3) viewing medication administration in multiple views.

In some embodiments, a view on the computer displays anesthesia basedinformation in an anesthesia view, as shown in FIG. 14A. Preferably,this view provides information about the patient and displays drugname/concentration and dose for a current injection as well as ahistorical list of medications that have been delivered to the patientsince the current case was opened. It may also include a listing ofinfusions given to the patient, if the clinician recorded them on theComputer. In this view, up to three injection bars display across thetop of the screen, one corresponding to each wirelessly connected flowsensor system 200. Each injection bar is a real time representation ofthe medication being administered through an individual flow sensorsystem 200. When an encoded syringe is attached to a single flow sensorsystem 200, the injection bar displays the drug name and concentration.When a non-encoded syringe is attached, the injection bar will promptthe clinician to identify the medication and concentration beingdelivered. As the medication is being delivered, the volume pushed (inmL) and the corresponding dose displays in real time in the injectionbar on the Computer display.

A flow sensor system 200 of the present disclosure may also provideoptional medication history. For example, an anesthesia view can includea historical list of medications delivered to the patient organized bythe surgical care area (medications given in the transition time betweencare areas, will post to the next care area) arranged in a flow sheetformat. Preferably, this view includes all medications that wereadministered to the patient since the flow sensor system 200 wasactivated with the more recent medication administrations preferably atthe bottom of the list. A scroll bar is enabled when the list exceedsthe visible space on the screen of the Computer. Preferably, when a newmedication is added, the medication list scrolls automatically so thenew medication name is visible. In the view, preferably a color tilecorresponding to American Society for Testing and MaterialsInternational (ASTM) standards and endorsed by the American Society ofAnesthesiologists displays to the left of the drug name. Optionally, aclinician may also specify that an admixture (mixed medication), or adiluted or reconstituted medication was delivered. Optionally, theComputer displays a case header which lists the patient name, date ofbirth, age in years, medical record number, and patient identificationnumber. Optionally, the Computer will indicate that the patient has “noknown allergies”. Preferably, if the patient has allergies, that text isreplaced by a button, more preferably, and the button has a number onthe button that indicates the number of allergies.

A flow sensor system 200 of the present disclosure may also provide anoptional tabular view, as shown in FIG. 14B. For example, the tabularview is an alternate view for the clinician to interact with the flowsensor system 200. Similar to the anesthesia view described above, thisview provides information about the patient and displays drugname/concentration and dose for a current injection as well as ahistorical list of medications that have been delivered to the patient.It may also include a listing of infusions given to the patient, ifrecorded by the clinician. The tabular view has many of the features ofthe anesthesia view; however, it is arranged in a tabular format.Preferably, the column headings in this view include time administered,medication with concentration, dose, and unit total. Optimally, themedications are displayed in reverse chronological order with mostrecent medication administered at the top of the list.

In one embodiment, the Computer provides two types of messages: (1)“Clinical” and (2) “System”. Clinical messages are alerts and remindersthat relate directly to an aspect of patient care delivery (e.g.contraindication or a reminder that it may be time to re-doseantibiotics). System messages provide status on relevant systemoperating parameters.

Messages provide instructions and a button for acknowledging orresolving. Messages display on the Computer until they are acknowledgedor are no longer clinically relevant. Messages can be answered any timeduring a case. Prior to pausing or closing a case, the clinician isprompted to respond/answer unresolved medication messages generatedduring the case. An allergy alert illuminates the flow sensor system 200and displays on the Computer when a clinician attaches an encodedsyringe or selects a medication for a non-encoded syringe to which thepatient has a known allergy. Optionally, this message may be overridden.

When dosing antibiotics, preferably the Computer tracks elapsed timesince an antibiotic was last administered and displays and announces anantibiotic redosing message if the configured redosing interval haselapsed. The redosing interval is individual to each antibiotic, and itis configured in the drug library of the Computer or Gateway (furtherdescribed below). In one embodiment, the flow sensor system 200 does notprevent or block the injection of a medication. In other embodiments,the flow sensor system 200 is able to block the injection of amedication.

In one embodiment, the Computer posts a message when the volume injectedthrough the flow sensor system 200 was not measured. This may occur whenthe volume measured is outside of a range of sensing of the flow sensorsystem 200.

Optionally, the Computer wirelessly communicates bi-directionally with asoftware application that acts as a central hub to which all Computers(and thus multiple upon multiples of flow sensor systems 200) areconnected, the “Gateway”. Preferably, the Gateway is also connected tothe hospital’s other networked information systems. The Gateway allowsall Computers to share patient case information such as drug name, dose,and time delivered with each other, and with the hospital’s networkedinformation systems. The Gateway also allows Computers to receivepatient information such as patient drug allergies and patient drugorders from other networked hospital information systems.

Utilizing the flow sensor system 200 of the present disclosureencompasses the steps of connecting the flow sensor 210 to the patient’scatheter or injection port (Y-site). Preferably, the flow sensor 210 andline is flushed. The flow sensor 210 is keyed to an individual patientusing a unique serial number and the base 220 records medicationadministration through the port at the inlet end 102 of the flow sensor210.

When a syringe 800 is attached to the injection port 130, the flowsensor system 200 identifies the medication and concentration for anencoded syringe by optically imaging and decoding a barcode on theLuer-Lok collar of the syringe 800. This information is wirelesslytransmitted to the Computer. Preferably, the Computer displays andaudibly announces the drug attached. The Computer also may performallergy safety checks based on the patient’s medical record.

In one embodiment, as the drug is injected, the flow sensor system 200measures the volume dosed ultrasonically. The flow sensor system 200wirelessly sends volume measurement information to the Computer. TheComputer uses this information to provide clinicians with a medicationadministration record which is time stamped and displays for clinicalreference during surgical procedures. Manually entered infusions andother information pertaining to non-encoded drug injections may beincluded in the patient medication record in the Computer and theGateway. The Computer wirelessly communicates with the Gateway on thehospital network, and it may send medication administration to HospitalInformation Systems, when configured, for reporting and electronicrecordkeeping purposes. Preferably, the Computer wirelessly communicateswith the existing Hospital Network using a standards based IEEE802.11a/b/g/n enterprise WLAN network. The Gateway software andaccompanied database will be a part of the hospital’s enterpriseinformation system. A number of Computers may be connected to thehealthcare enterprise wireless network and to the intended Gatewaysoftware and database. Preferably, the Gateway and accompanied databaseprovides a list of patients for the user to select and a formularylibrary of medications and fluids for injection or infusion. In oneembodiment, actual medication and fluid administration data are sent tothe Gateway and accompanied database for recordkeeping. Once recorded onthe Gateway and accompanied database these data are preferably availablein other care areas when the patient is transferred and the flow sensorsystem 200 is wirelessly connected to a Computer. Preferably, in theevent of a communication loss, medication administration data will notbe sent to the Gateway and therefore not available in the next carearea.

Referring to FIGS. 1-12 , use of a flow sensor system 200 of the presentdisclosure will now be described. First, preparing the flow sensorsystem 200 for an injection will be discussed.

In one embodiment, the flow sensor system 200 is prepared, attached toan IV line, and assembled for use. Preferably, there are pre-printedinstructions located on the flow sensor 210 sterility pouch. First, auser obtains a flow sensor 210 in its sterile packaging and afully-charged and disinfected reusable base 220. In one embodiment, afully-charged base 220 has sufficient power for at least 24 hours of useunder typical conditions. Optionally, the base 220 provides a visualindication of charge level via a display.

Next, the flow sensor 210 is flushed with sterile IV fluid beforeattaching to the Y-site. In one embodiment, the flow sensor 210 isflushed with more than 8 mL of sterile IV fluid. After flushing, a usercan visually inspect the IV line for leaks, air, or blockage.

Next, a user attaches the flow sensor 210 to the base 220 by joining theflow sensor 210 (tubing side) and base 220 front sections first, andthen snapping the two together. Preferably, an audible snapping sound isheard to indicate a secure connection between the flow sensor 210 andthe base 220. In one embodiment, connecting the flow sensor 210 to thebase 220 automatically powers on the flow sensor system 200. In oneembodiment, the connection of the flow sensor 210 to the base 220 isverified by a blinking light on the base 220. In other embodiments,other indicators may be used. Catch 389 of the base 220, shown in FIG.5A, engages tab 189 of the flow sensor 210, shown in FIG. 6 , torestrain the flow sensor 210 with the base 220 prior to initiation of aninjection. In one embodiment, deflection of the wing tab or wing tabs280 moves tab 189 with respect to catch 389 to initiate engagement ordisengagement therewith. When the flow sensor 210 is assembled to thebase 220, a cantilever 650 provided on the base 220, such as a lowerhousing 212 as will be discussed herein, is aligned with button 350provided on the base 220. The interior of the wing tab 280 may also beprovided with a pin cam 388 which allows pin 188 of the flow sensor 210,as shown in FIG. 6 , to ride along such that the flow sensor 210 ismoved proximally during assembly onto the base 220. During engagement,tongue 286 shown in FIG. 5A, is engaged within an opening 285 shown inFIG. 7 . With continued reference to FIGS. 5A and 7 , a vault 485 havingribs 487 on the flow sensor 210 as shown in FIG. 7 , has a correspondingexterior profile taken with the shoulder 486 of the base 220, as shownin FIG. 5A, to engage for alignment of the first window 360 to preciselyalign with Luer lock threads 131 when the flow sensor 210 is assembledto the base 220.

In some embodiments, where appropriate, the flow sensor system 200 issecured to a surface in preparation for giving injections. For example,in some embodiments, referring to FIG. 12 , a mount 1100 is used tosecure the flow sensor system 200 to a surface. During this step, it isimportant to avoid kinks in the line between the flow sensor system 200and IV line.

The flow sensor system 200 is now ready for delivery of IV medications.Preferably, any medications given through the flow sensor system 200will be recorded in the electronic base 220 memory. In one embodiment,in the event of a flow sensor system 200 failure (excluding the IV fluidpathway), the flow sensor system 200 will still allow standardmedication or fluid delivery through the port.

Next, giving an injection using the flow sensor system 200 will bediscussed. First, the injection port 130 is cleaned by swabbing the hubaccording to normal hospital procedure. Next, a syringe 800 can beattached to the injection port 130 of the flow sensor 210 by completelyturning the syringe 800 until the syringe 800 stops, i.e., a secureconnection between the syringe 800 and the injection port 130 is made.Ideally, the caregiver double checks each medication name andconcentration on the syringe 800 prior to attachment to the injectionport 130 to assure the correct medication is given. During the injectioncycle and/or medicament determination cycle, when syringe tip 810contacts a syringe protrusion 652, as shown in FIG. 4B, the cantilever650 is deflected radially from the longitudinal axis of the syringe 800.A pad protrusion 651 depresses button 350 on the base 220 and the button350 signals the microprocessor to act.

Next, the drug and concentration displayed and announced by the Computeris verified as the intended drug and concentration. In one embodiment,the base 220 will alert the caregiver that an allergy is detected by analert, for example, by flashing red, green, and yellow lights if amedication allergy is detected. Optionally, the Computer calculates apotential allergy reaction and provides an alert when any of theseconditions is true: (1) an encoded syringe is inserted into the flowsensor 210 and the drug matches the patient’s allergy profile; or (2) anon-encoded syringe is inserted into a flow sensor 210 and you select adrug from the select medication screen that matches the patient’sallergy profile. If one of these conditions is true, the allergy alertflag on the Computer configuration is turned on.

In one embodiment, there is no check valve in the flow sensor 210, noris one needed to use the flow sensor 210 safely and effectively.Typically, the flow sensor system 200 measures 0.4 mL to 55 mL perinjection. If the injection flow rate is slow or a small volume isdelivered (<0.4 mL) preferably an alert will display on the Computer.Optionally, an alarm is configured to detect rapid delivery from a largevolume, e.g., 50 mL syringe. In this case, an alert is provided to checkthe dose.

In one embodiment an indicator 375, such as a series of four LEDindicators, turn on in sequence to indicate to the user that fluid ismoving through the flow sensor 210. When base 220 is mounted in thecharger 900, the indicator 375 can indicate a level of battery charge ofthe base 220.

In one embodiment, it is preferred to follow all medication injectionsthrough the flow sensor system 200 with an encoded normal saline flushsyringe to ensure the full dose of medications reaches the patient,especially when successively delivering two incompatible medications.Optionally, the flow sensor system 200 records such saline flushactivity.

In one embodiment, injections are recorded whether or not the flowsensor system 200 is wirelessly connected to the Computer. The base 220stores injection information in its memory and transmits thisinformation upon wireless connection to the Computer.

In one embodiment, the Computer can accommodate multiple flow sensorsystems 200 connected to one patient at a time. An additional flowsensor system 200 may be added at any time during a patient’s treatment.When a flow sensor system 200 is connected to a Computer and there is nosyringe attached to the flow sensor 210, the active injection bar reads“Sensor Connected, No syringe”. On the Computer display, a batterystatus icon in the upper right corner of the injection bar indicates thebattery charge level of the base 220 to which the flow sensor 210 isconnected. For each injection a caregiver may enter a comment on theComputer.

The present disclosure provides a flow sensor sub-assembly for sensingflow of a fluidic medicament. The flow sensor sub-assembly includes afirst spring contact and a second spring contact. In one embodiment, thespring contacts are secured to a base that has a circuit for conductingan electrical signal to and from the spring contacts to amicroprocessor. The first spring contact is in electrical communicationwith a first piezo element and the second spring contact is inelectrical communication with a second piezo element. The first springcontact has a first contact force against the first piezo element andthe second spring contact has a second contact force against the secondpiezo element, and the first contact force is equivalent to the secondcontact force. The present disclosure also provides a circuit board forinterfacing to a flow sensor having a plurality of piezo elements fortransmitting a flow signal indicative of flow of a fluidic medicament.

A spring contact of the present disclosure provides electrical contactto a piezo element. For example, a spring contact of the presentdisclosure provides electrical contact to a silvered surface of apiezoelectric crystal. Furthermore this contact provides a spring forceselected to accommodate assembly tolerances, temperature variation,electrical requirements, material selection for a long life to silver,and assembly features for a single-sided printed circuit board assembly(PCBA) attachment. The flow sensor sub-assembly of the presentdisclosure provides for four contacts used in a sensor to have the sameforce on both surfaces of each of two piezo elements, such as crystals,in a single transducer.

A circuit board of the present disclosure provides a single-sided PCBA.The single-sided PCBA of the present disclosure provides a lower costdesign than conventional double-sided PCBA designs. The circuit board ofthe present disclosure also provides a means to maintain mechanicalloading of the crystal contacts when the transducer is inserted to thePCBA.

Electrical contacts to the ultrasound crystal have previously beenaccomplished by soldering wires to a silver coating. A spring contact ofthe present disclosure provides a cost reduction method by using thespring contacts to connect to the crystal. In particular, a single-sidedprinted circuit board (PCB) of the present disclosure provides for alower cost design and a through hole contact design. The design of thepresent disclosure includes the force exertion by the spring constant,dimension of separation between contacts, material type of the springs,the range of forces necessary, and tolerance control of forces exertedby the spring contact, which are all important to eliminate soldering.If soldering is too hot, it often takes silver off the surface of thecrystal. Another problem with soldering is leaving too much solderbehind, which may also cause loading of the ultrasonic physicalcharacteristics. Consistent electrical and physical contact(repeatability) for both crystals is important as well as sensor tosensor calibration. The forces cannot be too high (potential for aslurry to develop) or too low (variable impedance).

The flow sensor sub-assembly of the present disclosure provides a highvolume, disposable design with benefits for its cost, reliability, andrepeatability. The flow sensor sub-assembly of the present disclosureallows for future automation features. The flow sensor sub-assembly ofthe present disclosure provides for maximal tolerance designed inconditions. The flow sensor sub-assembly of the present disclosure isable to fit inside the housing of a flow sensor 210.

Referring to FIGS. 8 and 13-19B, a sub-assembly 10 for a flow sensor 210for sensing flow of a fluidic medicament generally includes a flow tube100 having a flow tube inlet 102 and a flow tube outlet 101, throughwhich a medicament flows, a first piezo element 150 arranged at anupstream position of the flow tube 100 and a second piezo element 151arranged at a downstream position of the flow tube 100, a first springcontact 750, and a second spring contact 750. In one configuration, thesub-assembly 10 for a flow sensor 210 may be utilized as a flow sensor210 and inserted into the base 220, where contacts 750 are integratedinto the base 220 rather than as a component of a housing 211, 212 ofthe flow sensor 210. Preferably, the upstream transducer 150 anddownstream transducer 151 are interchangeable, however, it is envisagedthat they may be purposefully constructed for their respective positionson the flow sensor sub-assembly 10.

In one embodiment, the first piezo element 150 and the second piezoelement 151 are mounted apart a pre-selected distance from each other.In one embodiment, each of the spring contacts 750 are secured to abase, e.g., a circuit board 700. The circuit board 700 includes acircuit for conducting an electrical signal to and from the springcontacts 750 to a microprocessor. The first spring contact 750 is inelectrical communication with the first piezo element 150 and the secondspring contact 750 is in electrical communication with the second piezoelement 151. The first spring contact 750 has a first contact forceagainst the first piezo element 150 and the second spring contact 750has a second contact force with the second piezo element 151. In oneembodiment, the first contact force is equivalent to the second contactforce.

Referring to FIGS. 8 and 13-19B, in one embodiment, the flow tube 100includes an inner flow tube 100 and end fittings, e.g., an inlet fitting180 at an inlet end 102 and an outlet fitting 190 at an outlet end 101,for securing the inner flow tube to the respective end fittings 180,190. In one embodiment, the first and second piezo elements 150, 151 aremounted to the end fittings 180, 190.

Referring to FIG. 16A-18 , in one embodiment, the first spring contact750 comprises a pair of cantilevered leaf springs 759 and the secondspring contact 750 comprises a pair of cantilevered leaf springs 759.Referring to FIGS. 17 and 18 , a cantilevered leaf spring 759 of thepresent disclosure may include tangs 756, a cantilever arm 757, and acontact area 758 having a bump 780.

Referring to FIG. 15 -16C, in one embodiment, the circuit that conductsan electrical signal to and from the spring contacts 750 to amicroprocessor is provided on a front and rear surface of a printedcircuit board 700 and the first and second spring contacts 750 areresiliently urged against the first and second piezo elements 150, 151,respectively, when the first and second piezo elements 150, 151 areinserted between each of the pair of cantilevered leaf springs 759.

In one embodiment, the circuit is formed integrally with a flow sensorhousing by injection molding. In one embodiment, referring to FIG. 8 ,the assembly may include a flow sensor upper housing 211 engageable witha flow sensor lower housing 212 about the flow sensor 210. In oneembodiment, the first piezo element 150 and the second piezo element 151are annular in shape and encircle the flow tube 100 at each respectivemounting point.

Referring to FIGS. 1-9 and 13-16C, in one embodiment, the flow sensor210 sub-assembly of the present disclosure is contained within a flowsensor housing 211, 212. A portion of the flow sensor housing 212 iscoupled to a flow sensor base 220 which contains a microprocessor and acircuit that includes connecting pins for providing an electrical signalfrom the flow sensor 210 sub-assembly to the microprocessor within theflow sensor base 220.

In some embodiments, the flow sensor 210 sub-assembly is disposed afterthe flow sensor 210 sub-assembly is used to sense the flow of at leastone fluidic medicament. In some embodiments, the flow sensor base 220 isreusable and is usable with different flow sensor 210 sub-assemblies.

Referring to FIGS. 8 and 13-19B, a circuit board 700 of the presentdisclosure for interfacing to a flow sensor 210 that includes piezoelements 150, 151 for transmitting a flow signal indicative of a flow ofa fluidic medicament includes a base or circuit board 700, a first pairof spring contacts 750, a second pair of spring contacts 750, and aplurality of pins 385 in electrical contact with a plurality ofelectrical circuit traces. In one embodiment, the circuit board 700includes a plurality of electrical circuit traces having a first end anda second end. In another embodiment, circuit board 700 can contain anon-volatile memory containing the serial number of the sensor 210,calibration data and/or flow calculation constants for communication tothe electronic microprocessor of the base 220.

Referring to FIG. 15 -16C, the first pair of spring contacts 750 forbias and electrical interface with a first piezo element 150 are mountedto a first end of the circuit board 700 and are in electricalcommunication with at least one electrical circuit trace. Also, thesecond pair of spring contacts 750 for bias and electrical interfacewith a second piezo element 151 are mounted to a second end of thecircuit board 700 and are in electrical communication with at least oneelectrical circuit trace. The plurality of pins 385 are in electricalcontact with the plurality of electrical circuit traces and configuredto form electrical contacts with the plurality of contacts 386. In oneembodiment, each of the spring contacts 750 are pre-configured such thatthe bias against the first piezo element 150 and the bias against thesecond piezo element 151 are equivalent and the electrical circuittraces are configured such that each of the pins 385 are in electricalcommunication with a single spring contact 750.

Referring to FIGS. 15-18 , in one embodiment, each pair of the springcontacts 750 comprise a pair of cantilevered leaf springs 759 mounted tothe circuit board 700. Referring to FIGS. 17 and 18 , a cantileveredleaf spring 759 of the present disclosure may include tangs 756, acantilever arm 757, and a contact area 758 having a bump 780. Theelectrical circuit traces are provided on a front surface of the circuitboard 700 and the spring contacts 750 extend from a rear surface of thecircuit board 700. In one embodiment, each of the cantilevered leafsprings 759 includes a mound-like protrusion, e.g., a bump 780, whichcontacts a surface of the piezo elements 150, 151.

In one embodiment, the circuit board 700 is formed integrally with aflow sensor housing 211, 212 by injection molding. The circuit board 700may be assembled into a flow sensor housing 211, 212 in at least twoorientations and provides transmission of a flow signal from the piezoelements 150, 151 to a microprocessor. In one embodiment, the circuitboard 700 is disposed of after a flow sensor 210 is used to sense theflow of at least one fluidic medicament. Advantageously, after a flowsensor 210 is used to sense the flow of at least one fluidic medicament,the circuit board 700 is usable with a different flow sensor 210.

Referring to FIGS. 16A-16C, the first spring contact 750 comprises apair of opposed cantilevered leaf springs 759 engaging an upstreamcontact point on the first piezo element 150 and a downstream contactpoint on the first piezo element 150, and the second spring contact 750comprises a pair of opposed cantilevered leaf springs 759 engaging anupstream contact point on the second piezo element 151 and a downstreamcontact point on the second piezo element 151.

Referring to FIGS. 16A-16C and 19B, in one embodiment, the first springcontact 750 comprises a bifurcated cantilevered leaf spring first half750 a engaging a first piezo element 150, and a bifurcated cantileveredleaf spring second half 750 b engaging the opposite side of the samepiezo element 150.

Referring to FIG. 20 , the flow tube sub-assembly 10 includes a flowtube 100, a first piezo element or upstream transducer 150, a secondpiezo element or downstream transducer 151, an inlet fitting 180, and anoutlet fitting 190.

Referring to FIG. 21 , the spring contacts 750 are secured to a circuitboard 700. In an exemplary embodiment, the nominal design of the springcontacts 750 on circuit board 700 are free standing with a 0.5 mmclearance. With a crystal, e.g., transducer 150 or 151, in place, thespring contacts 750 deflect outward and are loaded in a displacedposition of 0.75 mm with a nominal load of 75 g on each spring contact750 for a 100 g/mm design. From analysis, at 1 mm of deflection, theyield stress is near yield strength at a surface area of a large bend,which is satisfactory. The nominal springs measured 145 g/mm and 150g/mm.

With the contact gap at a minimum of 0.41 mm, the contact load increasesto a nominal value of 148 gms. Based on yield challenges and a margin to150 gm, the gap could be revised +/- 0.2 mm. If it does yield it willtake a set and still provide a spring force. Any reduction in thecrystal thickness will have an effect on the loaded condition and isevaluated. Another observation is the tolerance of the standoffs on thespring contacts 750 are larger than the dimension itself.

Referring to FIGS. 22A-22B, a portion of the flow sensor 210 at theoutlet end 101 is illustrated and tolerance analysis provided for anexemplary embodiment. In one embodiment, the transducer is parallel tothe base. As shown in FIGS. 22A-22B, the spring contacts are shown in anuncompressed state. As described herein, the deflection would betransitioned to the edge of the associated piezo element. Oneobservation is that the standoff tolerance of 0.13 mm is more than thestandoff itself of 0.05 mm on the spring contact 750. Referring to FIG.22B, the PCB surface may include dimples 730 for providing a planarreference. In one embodiment, the height of the dimples 730 is 0.05 mm.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A system, comprising: a computer; a flow sensorsystem configured to communicate with the computer, wherein the flowsensor system includes a flow sensor for sensing a flow of a fluidicmedicament administered through the flow sensor system; wherein thecomputer is configured to: receive, from the flow sensor system,information associated with the fluidic medicament; and control, basedon the information associated with the fluidic medicament received fromthe flow sensor system, a display to display, for the flow sensorsystem, a real-time representation of the fluidic medicamentadministered through the flow sensor system.
 2. The system of claim 1,wherein the real-time representation of the fluidic medicamentadministered through the flow sensor system includes a real-time volumeof the fluidic medicament administered through the flow sensor system.3. The system of claim 2, wherein the real-time representation of thefluidic medicament administered through the flow sensor system furtherincludes a real-time dose of a medication corresponding to the real-timevolume of the fluidic medicament administered through the sensor system.4. The system of claim 1, wherein the real-time representation of thefluidic medicament administered through the flow sensor system includesa drug name and a concentration of the fluidic medicament administeredthrough the flow sensor system.
 5. The system of claim 1, wherein thecomputer is further configured to control the display to display a listof medications previously delivered to a patient associated with theflow sensor system.
 6. The system of claim 1, wherein the flow sensorsystem further includes a base configured to be removably connected tothe flow sensor.
 7. The system of claim 6, wherein the base of the flowsensor system includes a rechargeable battery.
 8. The system of claim 6,wherein the flow sensor includes an injection port configured to beconnected to a syringe containing the fluidic medicament.
 9. The systemof claim 8, wherein the base includes a camera configured to read amachine readable indicia provided on a label of the syringe.
 10. Thesystem of claim 9, wherein the base of the flow sensor system includes afirst window and the camera disposed within or behind the first window,and wherein the first window is aligned with Luer lock threads on theflow sensor when the flow sensor is connected to the base to align themachine readable indicia on the label of the syringe with the camera.11. The system of claim 10, wherein the base of the flow sensor systemfurther includes a second window having a light source for providinglighting to the camera disposed within or behind window.
 12. The systemof claim 1, wherein the real-time representation of the fluidicmedicament administered through the flow sensor system includes aninjection bar on the display.
 13. The system of claim 1, wherein thereal-time representation of the fluidic medicament administered throughthe flow sensor system is arranged in a tabular format including columnheadings including a time administered, a medication with aconcentration, a dose, and a unit total.
 14. The system of claim 13,wherein the tabular format includes a list of medications previouslydelivered to a patient associated with the flow sensor system, andwherein the list of medications is displayed in reverse chronologicalorder with a most recent medication administered at a top of the list.15. The system of claim 1, wherein the computer is configured tocommunicate bidirectionally with a software application that acts as acentral hub.
 16. A method, comprising: sensing, with a flow sensor of aflow sensor system, a flow of a fluidic medicament administered throughthe flow sensor system; communicating, with the flow sensor system, to acomputer, information associated with the fluidic medicament; andcontrolling, with the computer, based on the information associated withthe fluidic medicament received from the flow sensor system, a displayto display, for the flow sensor system, a real-time representation ofthe fluidic medicament administered through the flow sensor system. 17.The method of claim 16, wherein the real-time representation of thefluidic medicament administered through the flow sensor system includesa real-time volume of the fluidic medicament administered through theflow sensor system.
 18. The method of claim 17, wherein the real-timerepresentation of the fluidic medicament administered through the flowsensor system further includes a real-time dose of a medicationcorresponding to the real-time volume of the fluidic medicamentadministered through the sensor system.
 19. The method of claim 16,further comprising: communicating, with the computer, the informationassociated with the fluidic medicament to a software application thatacts as a central hub.
 20. The method of claim 19, further comprising:receiving, with the computer, from the central hub, patient informationassociated with a patient associated with the flow sensor system.